Multiple SclerosisACE-MSNCT06718920
Adverse Childhood Experiences in Patients With MS: Impact on Quality of Life and on Coping Strategies Towards the Disease and Its Treatment
An observational study of Multiple Sclerosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The goal of this observational study is to evaluate the presence of adverse childhood experiences (ACE) in patients with Multiple Sclerosis. The main questions it aims to answer are: Does the presence of ACE impact on quality of life of patients with multiple sclerosis? Does it influence how the patients cope with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jan 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 500 Multiple Sclerosis patients referred to the Multiple Sclerosis Center of the Agostino Gemelli IRCCS University Polyclinic
Who may be able to join
- Age older than 18 years;
- Diagnosis of relapsing-remitting multiple sclerosis according to McDonald criteria (2017 revisions) made between 2014 and 2024.
- Signature of informed consent
Who cannot join
- Presence of language barrier
- Presence of conditions that prevent or limit understanding and proper completion of questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Massimiliano Mirabella, Neurology Associate Professor contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, RM, 00168
Massimiliano Mirabella, 0630155390, massimiliano.mirabella@policlinicogemelli.it
Alessandra Cicia, Neurologist
About this study
Official title: Single-center Observational Study to Characterize Adverse Childhood Experiences (ACE) in Patients With Multiple Sclerosis and Their Impact on Quality of Life, Disease Coping Strategies, and Adherence to Disease Course-modifying Therapies
The goal of this observational study is to evaluate the presence of adverse childhood experiences (ACE) in patients with Multiple Sclerosis. The main questions it aims to answer are:
- Does the presence of ACE impact on quality of life of patients with multiple sclerosis?
- Does it influence how the patients cope with the disease and with disease course-modifying therapies? During follow up visits, planned as part of their regular medical care, participants will answer survey questions on a tablet .
Read the detailed description
Multiple sclerosis is a chronic inflammatory, demyelinating, and neurodegenerative disease of the central nervous system, typically affecting young adults. Its etiopathogenesis is multifactorial, with the interaction of genetic susceptibility and environmental risk factors. Among these, childhood trauma and other forms of adverse childhood experiences (ACE) such as divorce or parental loss have been called out as possible risk factors in the development of MS and disease relapse.
Adverse Childhood Experiences are a heterogeneous group of negative experiences occurred during childhood, that may have an unfavorable impact on the later course of life in terms of physical and mental health. These effects may be related to changes in the prefrontal, limbic, and hypothalamic-pituitary-adrenal areas and may cause repercussions on the immune system, as documented on experimental models of autoimmune encephalitis. In addition to that, a history of ACE has been associated with the development of poor coping strategies during adulthood . Since multiple sclerosis represents a chronic and progressive disease, the kind of coping strategies developed from childhood may affect how the patient perceives the disease and may affect his or her adherence to treatment.
To date, data on the prevalence of traumatic events during childhood in patients with Multiple Sclerosis are limited to a few studies, while the impact of such events on how the patient copes with the diagnosis of disease and acceptance of therapy. has not yet been explored.
This study represents a preliminary analysis of the impact of ACE in a cohort of multiple sclerosis patients and aims to evaluate how early negative life experiences may affect patients' coping strategies towards the disease and their compliance to treatment.
- Conditions
- Multiple Sclerosis
- Keywords
- ACE, multiple sclerosis, treatment adherence, adverse childhood experiences, quality of life
- Medical subject headings
- Multiple Sclerosis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients referred to the Multiple Sclerosis Center of the Agostino Gemelli IRCCS | Patients diagnosed with multiple sclerosis between 2014 and 2024, referring to the Multiple Sclerosis Center of the Agostino Gemelli IRCCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis
The patients will answer to questionnaires provided on an electronic tablet during regular follow up neurological visits.
The presence of adverse childhood experiences will be explored through the completion of a specific questionnaire:
Childhood Trauma Questionnaire (CTQ): score 0-28 Higher scores mean higher probability to have experienced ACE
Measured: At enrollement
To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis
The patients will answer to questionnaires provided on an electronic tablet during regular follow up neurological visits.
The presence of dysfunctional parenting during childhood will be explored through the completion of the Measure of Parental Style (MOPS) questionnaire (score 0-28): higher scores mean higher probability to have experienced dysfunctional parenting, leading to ACE
Measured: At enrollement
Secondary outcomes (4)
To correlate the impact of ACE on quality of life and general distress
Quality of life and general distress will be assessed through Brief Symptom Checklist (BSC): score 0-53, higher scores mean higher distress and worse quality of life
Measured: 1 year
To correlate the impact of ACE on how the patient perceives and copes with the disease
Quality of life and physician-patient relationship satisfaction will be assessed through patient reported outcomes
Measured: 1 year
To correlate the impact of ACE on treatment adherence
Treatment satisfaction and compliance will be assessed through patient reported otcomes
Measured: 1 year
To correlate the impact of ACE on disease treatment
To explore treatment satisfaction through the analysis of the number of treatment switches for poor tolerability
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start13 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirabella Massimiliano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718920
- Sponsor's protocol ID
- 6791
- Acronym
- ACE-MS
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corallo F, Bonanno L, Di Cara M, Rifici C, Sessa E, D'Aleo G, Lo Buono V, Venuti G, Bramanti P, Marino S. Therapeutic adherence and coping strategies in patients with multiple sclerosis: An observational study. Medicine (Baltimore). 2019 Jul;98(29):e16532. doi: 10.1097/MD.0000000000016532.
PubMed 31335734Sheffler JL, Piazza JR, Quinn JM, Sachs-Ericsson NJ, Stanley IH. Adverse childhood experiences and coping strategies: identifying pathways to resiliency in adulthood. Anxiety Stress Coping. 2019 Sep;32(5):594-609. doi: 10.1080/10615806.2019.1638699. Epub 2019 Jul 9.
PubMed 31288568Nusslock R, Miller GE. Early-Life Adversity and Physical and Emotional Health Across the Lifespan: A Neuroimmune Network Hypothesis. Biol Psychiatry. 2016 Jul 1;80(1):23-32. doi: 10.1016/j.biopsych.2015.05.017. Epub 2015 Jun 4.
PubMed 26166230Khaw YM, Majid D, Oh S, Kang E, Inoue M. Early-life-trauma triggers interferon-beta resistance and neurodegeneration in a multiple sclerosis model via downregulated beta1-adrenergic signaling. Nat Commun. 2021 Jan 4;12(1):105. doi: 10.1038/s41467-020-20302-0.
PubMed 33397973McEwen BS. In pursuit of resilience: stress, epigenetics, and brain plasticity. Ann N Y Acad Sci. 2016 Jun;1373(1):56-64. doi: 10.1111/nyas.13020. Epub 2016 Feb 25.
PubMed 26919273Hepgul N, Pariante CM, Dipasquale S, DiForti M, Taylor H, Marques TR, Morgan C, Dazzan P, Murray RM, Mondelli V. Childhood maltreatment is associated with increased body mass index and increased C-reactive protein levels in first-episode psychosis patients. Psychol Med. 2012 Sep;42(9):1893-901. doi: 10.1017/S0033291711002947. Epub 2012 Jan 20.
PubMed 22260948Eid K, Bjork MH, Gilhus NE, Torkildsen O. Adverse Childhood Experiences and the Risk of Multiple Sclerosis Development: A Review of Potential Mechanisms. Int J Mol Sci. 2024 Jan 26;25(3):1520. doi: 10.3390/ijms25031520.
PubMed 38338799Spitzer C, Bouchain M, Winkler LY, Wingenfeld K, Gold SM, Grabe HJ, Barnow S, Otte C, Heesen C. Childhood trauma in multiple sclerosis: a case-control study. Psychosom Med. 2012 Apr;74(3):312-8. doi: 10.1097/PSY.0b013e31824c2013. Epub 2012 Mar 9.
PubMed 22408134Nikulina V, Widom CS. Child maltreatment and executive functioning in middle adulthood: a prospective examination. Neuropsychology. 2013 Jul;27(4):417-427. doi: 10.1037/a0032811.
PubMed 23876115
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Observational Study to Characterize Adverse Childhood Experiences (ACE) in Patients With Multiple Sclerosis and Their Impact on Quality of Life, Disease Coping Strategies, and Adherence to Disease Course-modifying Therapies
- ClinicalTrials.gov ID
- NCT06718920
- Acronym / sponsor ID
- ACE-MS / 6791
- Conditions
- Multiple Sclerosis
- Keywords
- ACE, multiple sclerosis, treatment adherence, adverse childhood experiences, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate the presence of adverse childhood experiences (ACE) in patients with Multiple Sclerosis. The main questions it aims to answer are:
- Does the presence of ACE impact on quality of life of patients with multiple sclerosis?
- Does it influence how the patients cope with the disease and with disease course-modifying therapies? During follow up visits, planned as part of their regular medical care, participants will answer survey questions on a tablet .
Detailed description
Multiple sclerosis is a chronic inflammatory, demyelinating, and neurodegenerative disease of the central nervous system, typically affecting young adults. Its etiopathogenesis is multifactorial, with the interaction of genetic susceptibility and environmental risk factors. Among these, childhood trauma and other forms of adverse childhood experiences (ACE) such as divorce or parental loss have been called out as possible risk factors in the development of MS and disease relapse.
Adverse Childhood Experiences are a heterogeneous group of negative experiences occurred during childhood, that may have an unfavorable impact on the later course of life in terms of physical and mental health. These effects may be related to changes in the prefrontal, limbic, and hypothalamic-pituitary-adrenal areas and may cause repercussions on the immune system, as documented on experimental models of autoimmune encephalitis. In addition to that, a history of ACE has been associated with the development of poor coping strategies during adulthood . Since multiple sclerosis represents a chronic and progressive disease, the kind of coping strategies developed from childhood may affect how the patient perceives the disease and may affect his or her adherence to treatment.
To date, data on the prevalence of traumatic events during childhood in patients with Multiple Sclerosis are limited to a few studies, while the impact of such events on how the patient copes with the diagnosis of disease and acceptance of therapy. has not yet been explored.
This study represents a preliminary analysis of the impact of ACE in a cohort of multiple sclerosis patients and aims to evaluate how early negative life experiences may affect patients' coping strategies towards the disease and their compliance to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred to the Multiple Sclerosis Center of the Agostino Gemelli IRCCS | – | –Patients diagnosed with multiple sclerosis between 2014 and 2024, referring to the Multiple Sclerosis Center of the Agostino Gemelli IRCCS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 500 Multiple Sclerosis patients referred to the Multiple Sclerosis Center of the Agostino Gemelli IRCCS University Polyclinic
Key inclusion criteria (3 listed)
- Age older than 18 years;
- Diagnosis of relapsing-remitting multiple sclerosis according to McDonald criteria (2017 revisions) made between 2014 and 2024.
- Signature of informed consent
Key exclusion criteria (2 listed)
- Presence of language barrier
- Presence of conditions that prevent or limit understanding and proper completion of questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis
Time frame: At enrollement
The patients will answer to questionnaires provided on an electronic tablet during regular follow up neurological visits. The presence of adverse childhood experiences will be explored through the completion of a specific questionnaire: Childhood Trauma Questionnaire (CTQ): score 0-28 Higher scores mean higher probability to have experienced ACE
To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis
Time frame: At enrollement
The patients will answer to questionnaires provided on an electronic tablet during regular follow up neurological visits. The presence of dysfunctional parenting during childhood will be explored through the completion of the Measure of Parental Style (MOPS) questionnaire (score 0-28): higher scores mean higher probability to have experienced dysfunctional parenting, leading to ACE
4 secondary outcomes
To correlate the impact of ACE on quality of life and general distress
Time frame: 1 year
To correlate the impact of ACE on how the patient perceives and copes with the disease
Time frame: 1 year
To correlate the impact of ACE on treatment adherence
Time frame: 1 year
To correlate the impact of ACE on disease treatment
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 31335734Corallo F, Bonanno L, Di Cara M, Rifici C, Sessa E, D'Aleo G, Lo Buono V, Venuti G, Bramanti P, Marino S. Therapeutic adherence and coping strategies in patients with multiple sclerosis: An observational study. Medicine (Baltimore). 2019 Jul;98(29):e16532. doi: 10.1097/MD.0000000000016532.
- Background: PubMed 31288568Sheffler JL, Piazza JR, Quinn JM, Sachs-Ericsson NJ, Stanley IH. Adverse childhood experiences and coping strategies: identifying pathways to resiliency in adulthood. Anxiety Stress Coping. 2019 Sep;32(5):594-609. doi: 10.1080/10615806.2019.1638699. Epub 2019 Jul 9.
- Background: PubMed 26166230Nusslock R, Miller GE. Early-Life Adversity and Physical and Emotional Health Across the Lifespan: A Neuroimmune Network Hypothesis. Biol Psychiatry. 2016 Jul 1;80(1):23-32. doi: 10.1016/j.biopsych.2015.05.017. Epub 2015 Jun 4.
- Background: PubMed 33397973Khaw YM, Majid D, Oh S, Kang E, Inoue M. Early-life-trauma triggers interferon-beta resistance and neurodegeneration in a multiple sclerosis model via downregulated beta1-adrenergic signaling. Nat Commun. 2021 Jan 4;12(1):105. doi: 10.1038/s41467-020-20302-0.
- Background: PubMed 26919273McEwen BS. In pursuit of resilience: stress, epigenetics, and brain plasticity. Ann N Y Acad Sci. 2016 Jun;1373(1):56-64. doi: 10.1111/nyas.13020. Epub 2016 Feb 25.
- Background: PubMed 22260948Hepgul N, Pariante CM, Dipasquale S, DiForti M, Taylor H, Marques TR, Morgan C, Dazzan P, Murray RM, Mondelli V. Childhood maltreatment is associated with increased body mass index and increased C-reactive protein levels in first-episode psychosis patients. Psychol Med. 2012 Sep;42(9):1893-901. doi: 10.1017/S0033291711002947. Epub 2012 Jan 20.
- Background: PubMed 38338799Eid K, Bjork MH, Gilhus NE, Torkildsen O. Adverse Childhood Experiences and the Risk of Multiple Sclerosis Development: A Review of Potential Mechanisms. Int J Mol Sci. 2024 Jan 26;25(3):1520. doi: 10.3390/ijms25031520.
- Background: PubMed 22408134Spitzer C, Bouchain M, Winkler LY, Wingenfeld K, Gold SM, Grabe HJ, Barnow S, Otte C, Heesen C. Childhood trauma in multiple sclerosis: a case-control study. Psychosom Med. 2012 Apr;74(3):312-8. doi: 10.1097/PSY.0b013e31824c2013. Epub 2012 Mar 9.
- Background: PubMed 23876115Nikulina V, Widom CS. Child maltreatment and executive functioning in middle adulthood: a prospective examination. Neuropsychology. 2013 Jul;27(4):417-427. doi: 10.1037/a0032811.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Massimiliano Mirabella, Neurology Associate Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massimiliano Mirabella, Neurology Associate Professor (0630155390, massimiliano.mirabella@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis (time frame: At enrollement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06718920, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.